CSS_CDRH-2026-133952_Final.docx

ALP: CDRH-2026-133952

Short Description: High-quality shake table for IMU verification and validation testing (+ software)

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00279 is issued as a/an ☐ RFQ ☐ RFP ☐ IFB for A Single-Axis Linear Motion Calibration System (Shake Table) with Control Software – A complete, turnkey laboratory calibration system capable of generating programmable linear motion profiles for verification, calibration, and validation testing of inertial measurement devices and related instrumentation. The system includes a precision linear motion platform, integrated position and acceleration sensors, closed-loop motion control, safety features, control software compatible with MATLAB and/or Python, factory calibration, calibration certificates, technical documentation, and all accessories necessary for installation and operation.

This acquisition ☐ is / ☒ is not set-aside for small business concerns.

Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: specify

NAICS Code: 334519 Small Business Size Standard: 600 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a ☒ quotation ☐ bid ☐ proposal, which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance:

U.S. Food and Drug Administration White Oak Building 62 Room 1135 10903 New Hampshire Ave, Silver Spring, MD 20993-0002

FOB Point: ☒ Destination ☐ Origin Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4. Final Government acceptance will occur after verification that the system was delivered without damage, contains all required components and accessories, includes the required calibration certificates and technical documentation, and successfully completes initial setup and functional verification. Government acceptance will establish the start date of the one-year warranty period.

Period of Performance Supplies: Delivery Timeframe + Warranty Delivery shall be completed within 90 days of award. The delivered items shall include a one (1) year warranty. The warranty period begins on the date of Government acceptance under the inspection and acceptance clause(s) of this contract.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

3. CONTRACT LINE ITEMS (CLINs)

Single-Axis Linear Motion Calibration System, Setup Support, Calibration Certificates and Technical Documentation, Warranty, Service Contact Information, VPAT/ Section 508 Documentation for Software

The system shall be fully assembled, factory-tested, and factory-calibrated prior to shipment, requiring only unpacking, cable connection, and software installation by the end user.

4. POINTS OF CONTACT

Contracting Officer:

Name: Maria Finan Email: Maria.Finan@fda.hhs.gov Phone: 240- 402-5712 Contract Specialist:

Name: Reagan Davis Email: Reagan.Davis@fda.hhs.gov Phone: 301-792-0910

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

c. 1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

e. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

f. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

g. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

h. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SPECIFICATIONS

The Food and Drug Administration (FDA) requires the acquisition of one (1) complete turnkey single-axis (one degree-of-freedom) linear motion calibration system for laboratory calibration, verification, and validation testing. The system shall be capable of generating programmable arbitrary motion profiles and include integrated position and acceleration sensors, closed-loop motion control, safety features, factory calibration, factory testing, calibration certificates, control software compatible with MATLAB and/or Python, technical documentation, and all accessories necessary for installation and operation. The system shall be fully assembled, factory-tested, and factory-calibrated prior to shipment, requiring only unpacking, cable connection, and software installation by the end user. The Contractor shall provide supplies meeting all specifications in Attachment 1 – Requirements.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Best Value Tradeoff (RFO 15.101): Award will be made to the responsible offeror whose quotation represents the best value to the Government, price and technical merit considered. Technical merit and price are approximately equal in importance. The Government may pay a modest premium for meaningfully higher technical merit but will not pay a large premium; as quotations approach equal technical merit, price becomes the deciding factor.

Technical evaluation has two parts. First, acceptability, assessed pass or fail: to be eligible for award, a quotation must demonstrate that the offered system meets every value in the “Acceptable” column of the Attachment 1 specification tables, together with the other mandatory requirements (motion architecture, safety features, standalone software and programmable interface, Section 508 conformance, delivery, and warranty). A quotation that fails to meet, or fails to demonstrate, any mandatory “Acceptable” requirement is ineligible for award and will not be evaluated further.

Second, technical merit, rated among acceptable quotations: the Government will evaluate the degree to which the offered system’s demonstrated performance reaches or approaches the “Preferred” values in Attachment 1. Performance at or toward the Preferred levels, supported by evidence, increases the Government’s confidence in the system and results in higher technical merit. Lower and well-characterized drift, supported by measured data, contributes to technical merit. Performance asserted without supporting evidence may be assessed as not demonstrated.

Price will be evaluated for reasonableness and weighed against technical merit in the tradeoff.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice by September 3, 2026. Questions and answers may be posted as an amendment to this solicitation on SAM.gov. Offerors shall submit an Accessibility Conformance Report (ACR), VPAT, or equivalent Section 508 conformance documentation for the proposed control software, if such documentation has been developed by the manufacturer. If no ACR/VPAT is available, the offeror shall affirmatively state that no such documentation is available.

Technical Response and Compliance Matrix – Offerors shall provide a completed matrix addressing each characteristic in Attachment 1 in order. For each characteristic, state whether the offered system meets the “Acceptable” value and, where it does, whether its performance reaches or approaches the “Preferred” value, and cite the supporting evidence (manufacturer specifications, measured performance data, or calibration certificates). Provide measured drift characterization data. A response that asserts compliance without supporting evidence may be evaluated as not demonstrated; failure to demonstrate any mandatory “Acceptable” requirement may render the quotation ineligible for award.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

1. Technical quotation with completed matrix

1. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Country of origin for all items

Points of Contact As listed on the SAM.gov notice.

C. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Attachments (if applicable):

Requirements

Trade Agreements Statements (conditional — RFO FAR 5.101(c)(4)(iii)):

One or more of the items under this acquisition is subject to Free Trade Agreements.

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)